PBSS free online symposium: Radio-labeled Mass Balance and Metabolite Profiling Studies: Fundamentals, Best Practices, Regulatory Requirements, Applications and Case Studies

NOTE: 1pm-5pm EST

Radio-labeled absorption, distribution, metabolism, and elimination (ADME) studies provide information related to rates and routes of elimination and major metabolic (excretory & circulatory) pathways of an investigational drug. The information generated with these studies is extremely valuable in predicting and explaining drug-drug interactions of parent/metabolites, as well as to understand the pharmacological and toxicological significance of metabolites. Regulatory guidelines (Metabolites in Safety Testing, MIST) warrant that human specific or disproportionate metabolites whose exposure is greater than 10% of total drug related material should be considered for safety assessment in preclinical species.

To establish quantitative metabolic pathways in laboratory animals and humans, a multitude of ADME studies are conducted at various stages of drug development utilizing radiolabeled compounds. Although radio-labeled ADME studies provide key information, there is limited regulatory guidance available on conducting these complex studies. In addition, recently there has been an increased interest in understanding the importance of the metabolism/catabolism of new modalities such as siRNAs and biologics.

The workshop is designed to provide detailed guidance on objectives, study designs, and data analysis of metabolism studies of small molecules, siRNAs, and protein therapeutics. Speakers of this workshop bring a wealth of knowledge from the pharmaceutical industry in drug metabolism sciences. The discussion will be centered around the following topics:

Overview of drug metabolism and regulatory requirements for IND and NDA submission
Preclinical and human mass balance studies: Design, data analysis, and interpretation
New crossover human ADME study design using AMS
Approaches for safety assessments of human metabolites
Techniques (H/D exchange, derivatization, NMR and stable isotope) beyond mass spectrometry for metabolite identification
Human dosimetry calculations
Radio-labeled ADME studies of new modalities